Corporate overview

On January 12, 2026 Aclaris therapeutics presented its corporate presentation.

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(Presentation, Aclaris Therapeutics, JAN 12, 2026, View Source [SID1234661933])

ACCENT data presented at 2026 ASCO Gastrointestinal Cancer Symposium

On January 12, 2026 Amplia therapeutics reported interim data from Phase 2a ACCENT trial in metastatic pancreatic cancer has been presented at the 2026 American Society for Clinical Oncology: Gastrointestinal Cancer Symposium (ASCO GI) in San Francisco.

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The poster presentation, delivered by Amplia’s Chief Medical Officer Dr Jason Lickliter, highlights updated efficacy and safety data for narmafotinib in combination with standard chemotherapy (gemcitabine and AbraxaneÒ).

Key points from the poster include:

The updated progression-free survival (PFS) is 7.7 months, compared to 5.5 months for Gemcitabine and Abraxane alone

The overall response rate (ORR) is 35%; this increases to 42% when including unconfirmed responses

Narmafotinib continues to be well tolerated by patients with the adverse effect profile of the narmafotinib-chemotherapy combination similar to chemotherapy alone

Amplia CEO, Dr Chris Burns, commented:
"We are pleased to present our research findings to clinicians and scientists at this conference, one of the world’s premier pancreatic cancer meetings. Presenting at ASCO (Free ASCO Whitepaper) GI positions Amplia among leading biotechnology and pharmaceutical companies internationally and underscores the company’s exciting progress in the development of narmafotinib in pancreatic cancer."

(Press release, Amplia Therapeutics, JAN 12, 2026, View Source [SID1234661923])

Swiss Rockets Group and Alloy Therapeutics Partner to Advance Radioligand Therapeutics in Oncology

On January 12, 2026 Swiss Rockets AG and Alloy Therapeutics, Inc. reported the signing of a Master Research Agreement (MRA) establishing a multi-target collaboration to discover and develop next-generation radioligand therapeutics (RLTs) for oncology. The collaboration will be executed through Swiss Rockets’ radiotherapeutics subsidiary, Torpedo Pharmaceuticals AG.

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Radioligand therapeutics are an emerging modality that can deliver radiation directly to tumor cells via highly selective targeting agents. Under the MRA, Alloy will provide access to its proprietary antibody discovery and engineering platforms, while Swiss Rockets and Torpedo will apply their radioisotope and radiopharmaceutical development expertise – including the use of Terbium-161 – to advance prioritized targets toward clinical development.

Collaboration highlights:

Multi-target oncology collaboration spanning discovery, engineering, and radiopharmaceutical development.
Access to Alloy’s enabling technologies for antibody discovery and optimization to generate high-quality targeting agents.
Torpedo-led radiochemistry, isotope integration, and translational development to advance RLT candidates toward the clinic.
"This agreement reflects Swiss Rockets’ strategy to unite cutting-edge discovery technologies with our translational and radiotherapeutic expertise. Together with Alloy, we aim to accelerate the emergence of next-generation cancer therapies through scientific and entrepreneurial collaboration. It exemplifies how strategic partnership and scientific innovation can speed the development of transformative oncology medicines," said Dr. Vladimir Cmiljanovic, Chief Executive Officer of Swiss Rockets AG and Torpedo Pharmaceuticals AG.

"Radioligand therapeutics represent an exciting frontier in oncology, and this partnership reflects Alloy’s broader mission to democratize access to enabling technologies and work with founders advancing breakthrough science," said Errik Anderson, Chief Executive Officer and Founder of Alloy Therapeutics. "We’re excited to collaborate with Swiss Rockets and Torpedo to help build a robust radioligand therapeutics capability that combines our discovery platforms with their radiotherapeutic infrastructure to deliver meaningful innovation for patients."

The parties intend to apply this framework to generate novel RLT candidates for high-value oncology targets and to accelerate translation from discovery into development-ready programs.

(Press release, Alloy Therapeutics, JAN 12, 2026, View Source [SID1234661914])

Castle Biosciences Announces Preliminary Unaudited Fourth Quarter and Full–Year 2025 Results

On January 11, 2026 Castle Biosciences, Inc. (Nasdaq: CSTL), a company improving health through innovative tests that guide patient care, reported certain unaudited preliminary performance results for the fourth quarter and year ended Dec. 31, 2025.

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"We are extremely pleased with our excellent fourth quarter and full year preliminary results, which reflect both the strength of our innovative test portfolio and the dedication of the entire Castle team," said Derek Maetzold, president and chief executive officer of Castle Biosciences. "We exited 2025 exhibiting strong execution and leadership across our dermatologic and gastrointestinal franchises and a strong balance sheet, positioning us well, we believe, to capitalize on our growth opportunities in 2026 and beyond. This includes the November 2025, limited access launch of AdvanceAD-Tx, our new test designed to help guide systemic treatment decisions for patients with moderate-to-severe atopic dermatitis, which materially expands our total addressable market."

Preliminary, Unaudited Fourth Quarter Ended Dec. 31, 2025, Highlights
Core revenue drivers:
•Fourth quarter 2025 total test reports for our core revenue drivers (DecisionDx-Melanoma, TissueCypher) increased 42% over the fourth quarter of 2024.
◦DecisionDx-Melanoma test reports delivered in the quarter were 10,022, compared to 8,672 in the fourth quarter of 2024.
◦TissueCypher Barrett’s Esophagus test reports delivered in the quarter were 11,803, compared to 6,672 in the fourth quarter of 2024.
Additional tests:
◦AdvanceAD-Tx was launched on a limited access basis in November 2025. Of the approximately 150 clinician offices that were granted access, more than 50% ordered AdvanceAD-Tx during the first five weeks of clinical availability.
◦DecisionDx-SCC test reports delivered in the quarter were 3,971, compared to 4,299 in the fourth quarter of 2024. Affecting fourth quarter test report volume was the change in Medicare coverage effective April 24, 2025, and re-focus of our commercial efforts.
◦MyPath Melanoma test reports delivered in the quarter were 1,045, compared to 879 in the fourth quarter of 2024.
◦DecisionDx-UM test reports delivered in the quarter were 395, compared to 424 in the fourth quarter of 2024.

Preliminary, Unaudited Year Ended Dec. 31, 2025, Highlights

•2025 total revenue expected to exceed $340 million, above the previously guided range of $327-335 million.
Core revenue drivers:
•2025 total test reports for our core revenue drivers (DecisionDx-Melanoma, TissueCypher) increased 37% over 2024:
◦DecisionDx-Melanoma test reports delivered in 2025 were 39,083, compared to 36,008 in 2024.
◦TissueCypher Barrett’s Esophagus test reports delivered in 2025 were 39,014, compared to 20,956 in 2024.
Additional tests:
◦DecisionDx-SCC test reports delivered in 2025 were 17,294, compared to 16,348 in 2024. Affecting twelve-month test report volume was the change in Medicare coverage effective April 24, 2025, and re-focus of our commercial efforts.
◦MyPath Melanoma test reports delivered in 2025 were 4,288, compared to 3,909 in 2024.
◦DecisionDx-UM test reports delivered in 2025 were 1,769, compared to 1,699 in 2024.
Discontinued tests:
◦IDgenetix test reports delivered in 2025 were 3,605, compared to 17,151 in 2024. The Company discontinued its IDgenetix test offering effective May 2025.

Cash, Cash Equivalents and Marketable Investment Securities
Year-end 2025 cash and cash equivalents are expected to be approximately $116 million. Additionally, the Company estimates that it held approximately $184 million in marketable investment securities as of year-end 2025.

(Press release, Castle Biosciences, JAN 11, 2026, View Source [SID1234662009])

Molecular Partners Highlights Clinical Development Progress and Anticipated Milestones at 44th Annual J.P. Morgan Healthcare Conference

On January 11, 2026 Molecular Partners AG (SIX: MOLN; NASDAQ: MOLN), a clinical-stage biotech company developing a novel class of protein drugs known as DARPin therapeutics ("Molecular Partners" or the "Company"), reported an update on its latest progress, developments plans and expected 2026 milestones, which it will present at the 44th Annual J.P. Morgan Healthcare Conference in San Francisco, California.

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"We are excited to have opened our Phase 1/2a trial in the US for MP0712, our Radio-DARPin targeting DLL3, and look forward to seeing initial clinical data in 2026. Our half-life optimized approach allows us to capitalize on the rapid target internalization to deposit more radiation compared to peptide-like approaches, affording us the ambition to become a leader in alpha-targeted radiotherapy in SCLC," said Patrick Amstutz, Ph.D., CEO of Molecular Partners. "Next to MP0726 targeting MSLN for ovarian cancer, we are working on 4 additional radiotherapy programs and will update on progress in H1 2026. In addition to our Radio-DARPin pipeline, we are progressing MP0317 and MP0533 in clinical trials, ideally led by investigators, and planning first Switch-DARPin candidates for development."

Cash and Cash Equivalents:
As of December 31, 2025, Molecular Partners reports cash and cash equivalents of CHF 93.1 million (unaudited). Based on current operating assumptions, this will be sufficient to fund operating expenses and capital expenditure requirements until 2028. The Company will provide full 2025 financial results on March 12, 2026.

Key current program status updates include:

MP0712 & Radio-DARPin pipeline

MP0712, the Company’s lead Radio-DARPin Therapy (RDT) based on 212Pb and targeting the tumor-associated protein delta-like ligand 3 (DLL3), is being developed with strategic partner Orano Med, pioneer in targeted alpha therapy, for the treatment of patients with small cell lung cancer (SCLC) and other neuroendocrine cancers. The Investigational New Drug (IND) application has been cleared and a Phase 1/2a trial has now started (ClinicalTrials.gov: NCT07278479). A first site is open and dosing of the first patient is expected in Q1 2026. The Phase 1/2a study is a multi-center study in the US, with the objectives to assess safety and determine a recommended phase 2 dose for MP0712. The study contains an imaging and dosimetry step with 203Pb-labeled MP0712. The Company expects initial clinical data from the study in 2026.

Molecular Partners presented new data on MP0712 at the Targeted Radiopharmaceuticals (TRP) Summit Europe in November 2025, highlighting first encouraging images of a patient receiving MP0712 carrying the diagnostic isotope 203Pb. The images, obtained through a Named Patient Access Program for compassionate care at NuMeRI in South Africa show targeted delivery of MP0712 into tumors and limited exposure in healthy organs such as kidney and liver, as intended. The NuMeRI team, led by Prof. Mike Sathekge, plans to report the full imaging and dosimetry data of MP0712 at the Theranostics World Congress (TWC) in January 2026.

The Company’s second RDT program MP0726, co-developed with Orano Med, targets mesothelin (MSLN), a tumor target overexpressed across several cancers with high unmet need, such as ovarian cancer. Molecular Partners has developed Radio-DARPins able to selectively bind to membrane-bound MSLN without being impacted by shed MSLN – a mechanism which has hampered the development of other MSLN-targeted therapeutics. The Company presented preclinical data on MP0726 at the 2025 Annual Meeting of the Society of Nuclear Medicine and Molecular Imaging (SNMMI) in June. The Company is planning to progress several Radio-DARPin programs towards first-in-human imaging, including MP0726.

Furthermore, Molecular Partners announced in December 2025 the formation of a scientific advisory board (SAB) to accelerate the development of its targeted radiotherapeutics. The SAB, chaired by globally recognized nuclear medicine expert Prof. Ken Herrmann, will be instrumental in guiding Molecular Partners strategic direction as it transitions and evolves from early clinical validation to full clinical development of its targeted alpha radiotherapies.

Molecular Partners has designed its Radio-DARPins as ideal vectors for precise delivery of potent alpha-emitting isotopes to tumor lesions and have the potential to unlock a broad range of solid tumor targets for radiopharmaceuticals.

MP0317 (tumor-localized CD40 agonist)

An investigator-initiated, proof-of-concept Phase 2 study of MP0317 in combination with standard-of-care for the treatment of patients with advanced cholangiocarcinoma is now open with two sites activated (NCT07036380). The first patient was treated in early 2026, additional sites are being activated and patients are in screening. The study is a randomized, multicenter study in France and aims to recruit 75 patients (50 in the experimental arm, 25 in the control arm). The objective of the study is to assess the clinical benefit of MP0317 combined with standard-of-care, which comprises the immunotherapy durvalumab (an anti-PD-L1 checkpoint inhibitor) plus gemcitabine-cisplatin-based chemotherapy.

MP0317 is designed to activate immune cells specifically within the tumor microenvironment by anchoring to fibroblast activation protein (FAP), which is expressed in high amounts in the stroma of various solid tumors. The Company completed a Phase 1 dose escalation study of MP0317 in patients with advanced solid tumors with 46 patients treated across 9 dose levels, and has presented comprehensive biomarker analyses from the trial at SITC (Free SITC Whitepaper) 2024 showing tumor-localized CD40 activation and tumor microenvironment remodeling. The Company believes this tumor-localized approach has the potential to deliver greater efficacy with fewer side effects compared to systemic CD40-targeting therapies.

MP0533 (multispecific T cell engager)

MP0533 is currently being evaluated in a Phase 1/2a clinical trial for relapsed/refractory acute myeloid leukemia (AML) and myelodysplastic syndrome/AML (NCT05673057).

Data presented at the 67th American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting in December 2025 showed that densified dosing appears tolerable, and leads to markedly improved serum exposure in cycle 1 and encouraging preliminary antitumor activity, in particular in patients with low bone marrow blast count at baseline. Cohort 10 is currently dosing patients, with an update on the program foreseen in H1 2026.

Molecular Partners plans to support the exploration of MP0533 in combination, both in patients with relapsed/refractory disease as well as in front-line, and has been approached by several consortia expressing interest in conducting such studies. The Company is actively engaging with key opinion leaders and regulators to shape the next phase of development, and anticipates updating the clinical plan for MP0533 in H1 2026.

MP0533 is a novel tetra-specific T cell-engaging DARPin designed for selective and broad killing of AML cells in a mutation-agnostic manner. MP0533’s mode of action enables T cell-mediated killing of AML cells – which commonly co-express at least two of the three targeted atigens (CD33, CD123, CD70) – while preserving a therapeutic window that minimizes damage to healthy cells, which normally express one or none of the targets.

Switch-DARPin (next-generation immune cell engagers)

Molecular Partners designed a logic-gated Switch-DARPin TCE to achieve conditional tumor-localized immune activation targeting MSLN and epithelial cell adhesion molecule (EpCAM), which are highly co-expressed in ovarian cancer and other solid tumors. The Switch-DARPin TCE is designed to unmask the CD3-engaging DARPin ("Switch" on) and to activate T cells only upon binding to both MSLN and EpCAM. This Switch-DARPin is half-life extended through a Fc domain, which broadens the Company’s capabilities in half-life engineering modalities.

Based on the encouraging pre-clinical data presented in 2025 at AACR (Free AACR Whitepaper) and SITC (Free SITC Whitepaper), the Company intends to nominate a lead Switch-DARPin candidate for development in H1 2026 and will provide an update on the program at AACR (Free AACR Whitepaper) 2026.

J.P. Morgan Presentation Details:

Presenter: Molecular Partners CEO Patrick Amstutz
Time: January 15, 2026, at 10:30-11:10AM PT (19:30-20:10 CET)
Location: The Westin St. Francis San Francisco, CA, USA.

A webcast will be accessible on the Molecular Partners website, under the Events tab.

(Press release, Molecular Partners, JAN 11, 2026, View Source [SID1234661959])